Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound

NCT03302221 | Withdrawn Phase 4 DMC

• 1 other identifier: 20170711-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the trial was to evaluate velocity-associated parameters of pulsed-wave Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during inspiratory cough in addition to the consumption of phenylephrine during the operation in patients undergoing video-assisted thoracic surgery with three types of anaesthesia management.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• The Change of end-diastolic velocity

  The primary outcome was the end-diastolic velocity at 12 time points of anaesthesia induction among the three groups.

  baseline and 10 minutes after induction

Secondary Outcomes (2)

• pulsed-wave Doppler ultrasound

  before leaving the PACU, up to 5 minutes

• intraoperative consumption of phenylephrine

  through study completion, an average of 3 hours

Study Arms (3)

Group control

OTHER

In the control group, local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.

Drug: 0.5% ropivacaine local anaesthesia

Paravertebral Block Group

EXPERIMENTAL

In Group Paravertebral Block, patients received standardized general anaesthesia supplemented by paravertebral Block. The USG approach for TPVB was used with the patient in the lateral position at the T4-T6 level according to the incision protocol in our centre.

Drug: 0.5% ropivacaine paravertebral block

Epidural Block Group

EXPERIMENTAL

The investigators designed a study to assess whether there were any blood flow indexes change during induction with doppler ultrasonography ;general anesthesia combined with epidural block

Drug: 0.25% ropivacaine epidural block

Interventions

0.5% ropivacaine paravertebral block DRUG

The investigators designed a study to assess whether there were any blood flow indexes change during induction with doppler ultrasonography after 0.5% ropivacaine paravertebral block

Paravertebral Block Group

0.25% ropivacaine epidural block DRUG

A 4-5 ml bolus of 0.25% ropivacaine was administered 1 h after the initiation of TEB.

Epidural Block Group

0.5% ropivacaine local anaesthesia DRUG

local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.

Group control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ethnic Chinese;
• age, 18 to 65 years old;
• American Society of Anaesthesiologists (ASA) physical status I or II;
• required VATS for lung surgery and one lung ventilation .

You may not qualify if:

• body mass index exceeding 30 kg/m2; Patients with a history of hypertension, diabetes mellitus or arteriosclerosis; and any allergy to drugs used in the study.
• Patients with arrhythmias or implanted cardiac pacemakers were excluded. Patients with diseases of the central or peripheral nervous system were excluded.
• Patients taking medications affecting the autonomic nervous system, such as b-blockers and calcium channel blockers

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hong Ma, MD,PhD

  Department of Anesthesiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate proffesor

Model Details: Doppler Ultrasonography Assessed Vascular Changes

Study Record Dates

• First Submitted: October 1, 2017
• First Posted: October 5, 2017
• Study Start: October 15, 2017
• Primary Completion: August 20, 2020
• Study Completion: September 20, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

CN (1)